BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)

    K Number: K002172 · Decision Aug 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    242
    Same Product Code
    173
    Applicant Total
    2
    Review Days
    405

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    Basic Information

    Device Name
    POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)
    K Number
    K002172
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xiros Plc
    Date Received
    July 19, 2000
    Decision Date
    August 28, 2001
    Product Code
    GAT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene

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    Other Clearances by Xiros Plc

    K Number Device Name
    K010051 POLY-TAPES WITH THE FASTLOK FIXATION DEVICE